AccessGUDID - DEVICE: Thrombin JMI 5,000 IU vial and 5 mL diluent (00360793215051)

GUDID

Device Identifier (DI) Information

Brand Name: Thrombin JMI 5,000 IU vial and 5 mL diluent
Version or Model: NDC 60793-215-05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Pfizer H.C.P. Corporation

Primary DI Number: 00360793215051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926582081 *Terms of Use

Device Description: Thrombin JMI 5,000 IU vial and 5 mL diluent with transfer device; A topical hemostat for application to the surface of bleeding tissues. See package insert for complete directions.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
44057	General surgical procedure kit, medicated	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: FALSE
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Milliliter
Device Size Text, specify: Syringe size

Device Record Status

Public Device Record Key: d33dd128-ede1-4e1c-be76-e202b02d920f
Public Version Date: June 17, 2022
Public Version Number: 5
DI Record Publish Date: April 23, 2019