What is FDA product code PDQ?

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

Ear Nose & Throat › DiagnosticNeurosurgical Nerve Locator

Bman Access Bevel Needle

Name: Bman Access Bevel Needle
Brand: Bman Access Bevel Needle

Catalogue number AAN-11-BMACS, listed by Surgentec LLC, United States, under Neurosurgical Nerve Locator. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PDQ
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42

Record

Regulatory record for Bman Access Bevel Needle
Listed by	Surgentec LLC, United States
FDA product code	PDQ
Device type	Neurosurgical Nerve Locator
Device class	Class 2
Regulation	21 CFR 874.1820
Establishment	Manufacturer
510(k)	K243945
Record published	2026-03-09
Record revised	2026-05-05 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Bman Access Bevel Needle
Catalogue number	Size	Status
AAN-11-BMACS		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pulse	Nuvasive, Inc.	21
Pediguard Threaded	Spineguard, SA	19
NVM5	Nuvasive, Inc.	15
Alara Neuro Access Needle Kit	Surgentec LLC	12
SafeOp	Alphatec Spine, Inc.	9
Sentio	Medos International Sàrl	8
TSI	Tedan Surgical Innovations, L.L.C.	8
SentioMMG	Innovative Surgical Solutions LLC	7
PediGuard DSG Connect	Spineguard, SA	6
Fresh Whole Blood Donor Transfusion Set	Safeguard US Operating, LLC	5
Arcus	Alphatec Spine, Inc.	4
Bendini	Nuvasive, Inc.	4

Showing 12 of 63. All products under Neurosurgical Nerve Locator

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K190163	2019-07-16

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.