AccessGUDID - DEVICE: Innomed, Inc. (00840277122520)

GUDID

Device Identifier (DI) Information

Brand Name: Innomed, Inc.
Version or Model: 8988
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8988
Company Name: INNOMED, INC.

Primary DI Number: 00840277122520
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878427491 *Terms of Use

Device Description: Gray Syringe Assist with Ergonomic Handle

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
62514	Syringe dispensing gun, reusable	A hand-held, manually-operated device intended to facilitate the infusion/dispensing of a high viscosity fluid or pressurized liquid (e.g., laminar stream) by assisting with the advancement of the syringe plunger. It includes a manually-squeezed lever mechanism (e.g., pistol-like) and is designed to accept a standard syringe (not included) whereby it is intended to increase the amount of force the user can apply to the syringe plunger based on leverage. It is not foot-operated and does not include a rotating crank mechanism. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQG	Adaptor, Holder, Syringe

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 6588f526-24fc-4629-8b25-1ac43567b784
Public Version Date: November 09, 2021
Public Version Number: 2
DI Record Publish Date: October 06, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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