AccessGUDID - DEVICE: INSUFFLATION NEEDLE,12CM (00858690006204)

GUDID

Device Identifier (DI) Information

Brand Name: INSUFFLATION NEEDLE,12CM
Version or Model: 14GA x 12 CM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IN-12
Company Name: RANFAC CORP.

Primary DI Number: 00858690006204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121622872 *Terms of Use

Device Description: INSUFFLATION NEEDLE,12CM PN 68017-01M

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?
12750	Spring-loaded pneumoperitoneum needle, single-use	A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHO	Pneumoperitoneum Needle

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930474	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 14 Gauge
Length: 12 Centimeter

Device Record Status

Public Device Record Key: 54a1d125-f725-4e8e-a62a-802f7767c571
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 08, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20858690006208	16	10858690006201		In Commercial Distribution	Case
10858690006201	10	00858690006204		In Commercial Distribution	Inner Pack

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: 5085884400
Email: info@ranfac.com

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