AccessGUDID - DEVICE: SANDEL (25414566810284)

GUDID

Device Identifier (DI) Information

Brand Name: SANDEL
Version or Model: 2211-NNS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2211-NNS
Company Name: Ansell Sandel Medical Solutions LLC

Primary DI Number: 25414566810284
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 107961166 *Terms of Use

Device Description: WEIGHTED SAFETY SCALPEL, #11 BLADE, BULK (NS)

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):	No
Over the Counter (OTC):	Yes
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?
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDX	Scalpel, One-Piece

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 [?]
Radiation 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: 619bd751-b8a0-4781-812a-19d2c0a9480a
Public Version Date: April 05, 2022
Public Version Number: 1
DI Record Publish Date: March 28, 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
35414566810281	1	25414566810284		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00071483005257 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 775-746-6600
Email: jacob.ramirez@ansell.com

Phone: 775-470-7106
Email: don.cronk@ansell.com

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