What is FDA product code MLS?

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Obstetrics & Gynecology › SurgicalLabor And Delivery Kit

Instrapac

Name: Instrapac
Brand: Instrapac

Instrapac Delivery Pack with Drape and Large XRD swabs. 20 packs per Case. Contents: 1 x Umbilical Cord Scissors 10cm/4in, 1 x Mayo Scissors Curved 17cm/6.75in, 2 x Spencer Wells Forceps…

Registry build 21.09.26

Instrapac Delivery Pack with Drape and Large XRD swabs. 20 packs per Case. Contents: 1 x Umbilical Cord Scissors 10cm/4in, 1 x Mayo Scissors Curved 17cm/6.75in, 2 x Spencer Wells Forceps Straight 18cm/7in, 2 x Umbilical Cord Clamps, 5 x Large XRD Swabs 30cm x 30cm (12in x 12in), 1 x Drape 90cm x 90cm (35in x 35in). Provided in a crepe paper wrap.

1manufacturer

4catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code MLS
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for Instrapac
Listed by	Robinson Healthcare Limited, United Kingdom
FDA product code	MLS
Device type	Labor And Delivery Kit
Device class	Class 2
Regulation	21 CFR 884.4530
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2022-08-12
Record revised	2026-02-12 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Keep dry and keep out of sunlight
Packaging	Box of 20, case = 20 packs of 20
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Instrapac
Catalogue number	Size	Status
7386		In distribution
8774 Delivery Pack with Drape and Large XRD swabs		In distribution
7017 Delivery Pack – 18cm/7in Forceps		In distribution
7821		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	3,909
Medline Industries, Inc.	Medline Industries, Inc.	3,405
ACS	American Contract Systems, Inc.	244
Centurion	Centurion Medical Products Corporation	159
Regard™	ROi CPS LLC	125
Regard™	Resource Optimization & Innovation, L.L.C.	63
Centurion Medical Products Corp	Medline Industries, Inc.	29
Aligned Medical Solutions	Aligned Medical Solutions	16
Medical Action Industries	Medical Action Industries, Inc.	11
Medline	Medline Industries, Inc.	6
Halyard	Avid Medical, Inc.	6
Devon	Cardinal Health	4

Showing 12 of 16. All products under Labor And Delivery Kit

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.