AccessGUDID - DEVICE: NA (06932503533065)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: IN12-195232302
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IN12-195232302
Company Name: Micro-Tech (Nanjing) Co., Ltd.

Primary DI Number: 06932503533065
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530269083 *Terms of Use

Device Description: POM inner tuber,Needle Length 5mm,with metal cap 19G*5*2.3*230,Shroat stucture

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?
45019	Submucosal injection needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBK	Endoscopic Injection Needle, Gastroenterology-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150434	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
No Device Sizes

Device Record Status

Public Device Record Key: 7d9b80a9-87fa-48fd-90b9-bdfe7f80ac3a
Public Version Date: April 12, 2021
Public Version Number: 4
DI Record Publish Date: March 10, 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
26932503533069	10	16932503533062		In Commercial Distribution	case
16932503533062	10	06932503533065		In Commercial Distribution	box

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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