Surgical Direct

Dingman Mouth Gag Complete Set, 3 Tongue Blades, 2 Adjustable Upper Blades, 2 Cheek Retractors, Grooved Tongue Blades, Coil Springs on Upper Frame for Suture Handling

Registry build 21.09.26
3manufacturers in China registered for this device type
408catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1).

Chinese manufacturers registered for FDA product code FGN
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Wilpower Industrial Co., Ltd. Shanghai Shanghai Exporter 33

Record

Regulatory record for Surgical Direct
Listed by Surgical Direct, Inc., United States
FDA product code FGN
Device type Retractor, Non-Self-Retaining
Device class Class 1
Regulation 21 CFR 876.4730
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2024-07-02
Record revised 2024-10-15 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Latex Contains natural rubber latex
Label carries lot or batch number
Distribution end date 2024-12-31

Catalogue Numbers

Catalogue numbers for Surgical Direct
Catalogue number Size Status
SD914178104 In distribution
SD914221101 In distribution
SD90738400T In distribution
SD91904615 In distribution
SD914178111 In distribution
SD165160 In distribution
SD90800214 In distribution
SD934117034 In distribution
S35800.100 In distribution
S3787.104 In distribution
SD93411781 In distribution
SD914178102 In distribution
S34015.103 In distribution
SD914178147 In distribution
SD14172-0900 In distribution
SD91912515 In distribution
SD209942-FS-AN In distribution
SD919073200 In distribution
S3447-01 In distribution
SD919126162 In distribution
SD14172-2800 In distribution
SD15531012 In distribution
SD155185C In distribution
SD91417116 In distribution
SDM32670 In distribution
SD914178106 In distribution
SD155170E In distribution
SD14796-1000 In distribution
SD93941.400 In distribution
S34122.070 In distribution
SD914178112 In distribution
SD919069100 In distribution
SD64270 In distribution
SD914795102 In distribution
SD90803003 In distribution
SD91417830 In distribution
SD14178-3000 In distribution
SD90803004 In distribution
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SD14178-1220 In distribution
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SD914105111 In distribution
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SDM32200 In distribution
SD9387220 In distribution
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SD93411700 In distribution
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SD14178-012 In distribution
SD1363.100 In distribution
SD934117100 In distribution
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S34398.111 In distribution
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SD92386249 In distribution
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SD93411512 In distribution
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SD919069101 In distribution
SD1365.101 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Omni-Tract® Integra Lifesciences Corporation 252
Orthomed Ortho-MED, Inc. 205
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 47
Wexler Surgical, Inc. Wexler Surgical, Inc. 26
V. Mueller Steris Corporation 24
Novo Surgical Novo Surgical, Inc. 24
Novo Surgical Inc. Novo Surgical, Inc. 18
Ambler Surgical Ambler Surgical, LLC 16
Tebbetts Suction Wound Retractor Sontec Instruments, Inc. 12
Cochran Pediatric Retractor Sontec Instruments, Inc. 10
Pilling Teleflex Medical LLC 10
Hill-Ferguson Retractor Sontec Instruments, Inc. 8

Showing 12 of 51. All products under Retractor, Non-Self-Retaining

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer