AccessGUDID - DEVICE: GEN2 (00840343723347)

GUDID

Device Identifier (DI) Information

Brand Name: GEN2
Version or Model: G2C62410
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G2C62410
Company Name: SURGIX MEDICAL LLC

Primary DI Number: 00840343723347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080402644 *Terms of Use

Device Description: ALLISON LUNG RETRACTOR, 54MM, 12 1/2"

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?
35345	Lung spatula	A hand-held manual surgical instrument designed to manipulate the pulmonary tissue/surfaces of the lungs during a surgical intervention in the thorax. It typically consists of a large flat blunt blade (no sharp edges) at the distal end and a strong handle at the proximal end. It is usually made of stainless steel and is available with a variety of blade designs, e.g., curved and flat with a protected rounded end, a wire basket structure of interconnected round wires, or broad and flat with fenestrations. The blade and handle can be designed to be at various ergonomic angles to each other. This instrument is sometimes referred to as a lung retractor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAF	Spatula, 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
Length: 12.5 Inch

Device Record Status

Public Device Record Key: 87afca9e-4679-4db0-89f9-50ce07147733
Public Version Date: September 26, 2024
Public Version Number: 1
DI Record Publish Date: September 18, 2024

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: 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 888-247-0477
Email: customerservice@surgixmedical.com

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