FDA.report

EXAM ROBE

Primary DI
00634916110012
Brand
EXAM ROBE
Company
STANDARD TEXTILE CO., INC.
Model
74933450
Catalog number
74933450
Device description
EXAM ROBE HEAL SPACES OLIVE L KNIT SNAP FRONT CLOSING
Published
2018-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMEGown, Examination

Product Code Classifications

CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634916110012PrimaryGS10
10634916110012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634916110012006349161100126349161100120634916110012
1063491611001210634916110012

GMDN Terms

TermDefinition
Patient gown, reusableA garment made of natural and/or synthetic materials (e.g., cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and is closed by ties at the back/side of the garment. This is a reusable garment.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-999-0400GUDID@standardtextile.com

Regulatory Flags

DUNS number
006999858
Device count
48
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00634916019353Standard Supreme966893632026-03-11
00634916099225INSTRUMENT COVER965005122026-03-11
00634916120905Instrument Holder969007152026-03-11
00634916349740Compel MLR OR Gown7567B2162026-03-11
00634916781373WrapPel Table Cover969017842026-03-11
00634916788105Compel MLR OR Gown756747432026-03-11
00634916788112Compel MLR OR Gown756747442026-03-11
00634916788129Compel MLR OR Gown756747452026-03-11
00634916789249ProMax Surgical Gown756747652026-03-11
00634916789256ProMax Surgical Gown,756747642026-03-11
00634916789263ProMax Surgical Gown,756747632026-03-11
00634916792775OR Gown756748362026-03-11
00634916796322ComPel Surgical Gown756566G32026-03-11
00634916796339ComPel Surgical Gown756566G42026-03-11
00634916796346ComPel Surgical Gown756566G52026-03-11
00634916797114Reusable Gown 661YUAG42026-03-11
00634916797121Reusable Gown661YUAG52026-03-11
00634916797459ComPel Isolation Gown6610359V2026-03-11
00634916829358ProMax Surgical Gown756150762026-03-11
00634916870633Instrument Drape966008322026-03-11

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