FDA.report

7720 METRO SEAL

Primary DI
00874750002870
Brand
7720 METRO SEAL
Company
HANS RUDOLPH, INC.
Model
7720
Catalog number
669353
Device description
METRO SEAL
Published
2018-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00874750002870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00874750002870008747500028708747500028700874750002870

GMDN Terms

TermDefinition
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter, lamp); it is not hypoallergenic or waterproof. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007131725
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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