AccessGUDID - DEVICE: ENDOSCOPIC SEAL (M648C0100130)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSCOPIC SEAL
Version or Model: C010013
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C010013
Company Name: OBP CORPORATION

Primary DI Number: M648C0100130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011560431 *Terms of Use

Device Description: ENDOSCOPIC SEAL GYN 1 SIZE FITS ALL

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?
60650	Endoscope working-channel seal	A sterile device intended to be fitted over the working channel access port of an endoscope to minimize leakage of liquids and gases through the working channel, while permitting entry of endoscopic devices. It is typically a small plastic Luer attachment with an intraluminal seal. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ODC	Endoscope Channel Accessory

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between 5 and 35 Degrees Celsius
Handling Environment Humidity: between 45 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 136f5dbb-326b-4db9-83ee-a1b88b142444
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M648C0100131	10	M648C0100130		In Commercial Distribution	Bag

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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