AccessGUDID - DEVICE: N/A (00840329814359)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: B89IGS-60CC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B89IGS-60CC
Company Name: BLACK & BLACK SURGICAL, INC.

Primary DI Number: 00840329814359
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004382282 *Terms of Use

Device Description: INJECTION GUN FOR MONOJECT TOOMEY 60CC SYRINGE

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):	Yes
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?
37589	Syringe autofill kit	A collection of sterile devices designed to deliver (autofill) fluids (e.g., a dilute lidocaine solution for local anaesthesia) from an intravenous (IV) bag to a syringe so that the syringe is conveniently refilled, thus eliminating the need for multiple reconnections to the solution container. It is typically made of plastic materials and consists of a 12 cc control syringe, IV tubing with a spike, check valve and tubing clamp, and an extension line. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

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: 673b001b-ef00-4335-81f8-3fd764404957
Public Version Date: September 29, 2022
Public Version Number: 1
DI Record Publish Date: September 21, 2022

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: +1(770)414-4880
Email: info@blackandblacksurgical.com

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