AccessGUDID - DEVICE: INTEGRA® (00650551036739)

GUDID

Device Identifier (DI) Information

Brand Name: INTEGRA®
Version or Model: 3614ES-193-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3614ES-193-2
Company Name: PMT CORPORATION

Primary DI Number: 00650551036739
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039576871 *Terms of Use

Device Description: TISSUE EXPANDER, CURVE, ENHANCED TEXTURED SURFACE, 2-STAGE

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:	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?
45187	Skin-port tissue expander	An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.	Active	true

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FDA Product Code

Product Code	Product Code Name
LCJ	Expander, Skin, Inflatable

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K845036	000

Sterilization

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

Storage and Handling
Storage Environment Temperature: between 58 and 78 Degrees Fahrenheit

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Clinically Relevant Size

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Size Type Text
Length: 6 Centimeter
Device Size Text, specify: Projection 3.5 Centimeter
Total Volume: 50 Centiliter
Width: 2.5 Centimeter

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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

Customer Contact

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DEVICE: INTEGRA® (00650551036739)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact