AccessGUDID - DEVICE: Instrapac (05010058078215)

GUDID

Device Identifier (DI) Information

Brand Name: Instrapac
Version or Model: 7821
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7821
Company Name: ROBINSON HEALTHCARE LIMITED

Primary DI Number: 05010058078215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 237799775 *Terms of Use

Device Description: Instrapac Delivery Pack - 18cm Forceps X 20 Contents: 1 x Umbilical Cord Scissors 10cm, 1 x Mayo Scissors Straight 17cm, 2 x Spencer Wells Forceps Straight 18cm, 2 x Umbilical Cord Clamps, 1 x PP tray with 2 Integral Pots. Provided in a crepe paper wrap.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34988	Birthing/delivery kit	A collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLS	Labor And Delivery Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 494cdbd8-028e-4391-8497-2a57dea9257e
Public Version Date: May 29, 2025
Public Version Number: 1
DI Record Publish Date: May 21, 2025