FDA.report

MEDI

Primary DI
00636257111444
Brand
MEDI
Company
MEDI MANUFACTURING, INC.
Model
BK1L0N3
Device description
20-30 SHRINKER BK 18" LONG BEIGE SZ 3
Published
2018-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
IPMCOVER, LIMB

Product Code Classifications

CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00636257111444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00636257111444006362571114446362571114440636257111444

GMDN Terms

TermDefinition
Limb coverA device made of fabric or harder materials designed to protect or aid in the use of a cast, orthosis, or prosthesis by being placed over the limb as a cover. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-6334info@mediusa.com

Regulatory Flags

DUNS number
960754430
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00636257157640MEDI195512016-09-23
00636257157657MEDI195522016-09-23
00636257157664MEDI195532016-09-23
00636257157671MEDI195542016-09-23
00636257157688MEDI195552016-09-23
00636257157695MEDI195562016-09-23
00636257157701MEDI195572016-09-23
00636257157718MEDI196512016-09-23
00636257157725MEDI196522016-09-23
00636257157732MEDI196532016-09-23
00636257157749MEDI196542016-09-23
00636257157756MEDI196552016-09-23
00636257157763MEDI196562016-09-23
00636257157770MEDI196572016-09-23
00636257158272MEDI296512016-09-23
00636257158289MEDI296522016-09-23
00636257158296MEDI296532016-09-23
00636257158302MEDI296542016-09-23
00636257158388MEDI296552016-09-23
00636257158395MEDI296562016-09-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20809160489885Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-08-01
20809160489465Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-07-31
08717127934409Arion Easy-Slide Arion Holding B.V.IPM2025-02-03
08717127934416Arion MagnideArion Holding B.V.IPM2025-02-03
08717127934423Arion Sim-Slide Arion Holding B.V.IPM2025-02-03
08717127934430Arion Easy-OffArion Holding B.V.IPM2025-02-03
08717127934447Arion Easy-Slide ArmArion Holding B.V.IPM2025-02-03
08717127934454Arion Proth-ProArion Holding B.V.IPM2025-02-03
08717127930111Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930401Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930432Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930463Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930494Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930555Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930586Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930616Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930647Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930678Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930708Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930739Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930760Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930791Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930821Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930852Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930883Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930913Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930944Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930975Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931002Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931040Arion SlideXArion Holding B.V.IPM2025-01-13