AccessGUDID - DEVICE: Medline (10080196806485)

GUDID

Device Identifier (DI) Information

Brand Name: Medline
Version or Model: DYND70401S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DYND70401S
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10080196806485
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: SPECULUM,VAGINAL,SMALL,LIGHT,DISPOSABLE

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?
13392	Vaginal retractor, self-retaining	A self-locking, surgical instrument, used for separating the edges of the vagina and holding back the tissue allowing a surgical intervention or examination. The instrument may resemble a large pair of scissors or have an open circle design with pointed, blunted, or wire-like blades or claws that grasp and part the tissue of the vaginal opening. It is typically made of stainless steel and comes in a variety of designs. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HIB	Speculum, vaginal, nonmetal

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Label does not mention Storage Conditions

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 48081dad-81a5-4b6e-b2c1-d98aa89b3d26
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 14, 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
30080196806489	25	10080196806485		In Commercial Distribution

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: Yes
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: +1(800)633-5463
Email: service@medline.com

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