AccessGUDID - DEVICE: ETHICON (10705031230132)

GUDID

Device Identifier (DI) Information

Brand Name: ETHICON
Version or Model: 3921S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3921S
Company Name: Ethicon Inc.

Primary DI Number: 10705031230132
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 002144145 *Terms of Use

Device Description: Evicel Airless Spray Accessory

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:	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?
64222	Haematological concentrate/haemostatic agent applicator cannula, open-surgery	A flexible or rigid tube intended to be used during an open surgical procedure for the administration of a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, polysaccharide) to a bleeding surgical site, typically to facilitate haemostasis and healing, in conjunction with an applicator such as a syringe/plunger [not included]. It may have a single channel, to administer one product, or dual channels for co-administration of two different agents simultaneously; a channel for connection to a gas pump for spraying may also be incorporated. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZM	Fibrin sealant preparation device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK140093	0

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: less than 30 Degrees Celsius
Storage Environment Temperature: less than 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 93268a0d-942e-46e5-8722-4dfaceedf977
Public Version Date: July 17, 2025
Public Version Number: 8
DI Record Publish Date: September 23, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20705031230139	10	10705031230132	2023-03-15	Not in Commercial Distribution	BOX
30705031230136	10	10705031230132	2023-03-15	Not in Commercial Distribution	CASE

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)384-4266
Email: xxx@xxx.xxx

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