AccessGUDID - DEVICE: SURGICEL (10705031237513)

GUDID

Device Identifier (DI) Information

Brand Name: SURGICEL
Version or Model: 3123SPEA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3123SPEA
Company Name: ETHICON, LLC

Primary DI Number: 10705031237513
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829465157 *Terms of Use

Device Description: Endoscopic Applicator

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?
52751	Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use	A long flexible or rigid tube with an atraumatic tip intended to be used during an endoscopic/laparoscopic procedure to provide access 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 [not included]. It is designed to be inserted into the body percutaneously, via a port or endoscope/laparoscope. It may have a single or dual-channel(s) for administration of one or two agent(s); a channel for connection to a gas pump for spraying may be incorporated. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMG	Agent, absorbable hemostatic, non-collagen based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
N12159	047

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
Special Storage Condition, Specify: Do not use if package is damaged

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 34030087-c4ed-4fd9-814e-2efa4ff785d0
Public Version Date: November 06, 2020
Public Version Number: 3
DI Record Publish Date: May 13, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20705031237510	5	10705031237513		In Commercial Distribution	BOX

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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