FDA.report

Medline-Microtek

Primary DI
00748426262854
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Patient Drapes
Catalog number
ISO1018N
Device description
Patient Drape, ISODrape™ Instrument Pouch Drape, 17 cm x 30 cm (7 in x 12 in)
Published
2026-01-02
Public version status
New
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

Contact Domains

Product Codes

CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20748426262858PrimaryGS10
00748426262854Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2074842626285820748426262858
00748426262854007484262628547484262628540748426262854

GMDN Terms

TermDefinition
Instrument management bagA flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
1-800-633-5463customerservice@medline.com

Regulatory Flags

DUNS number
106908437
Device count
100
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
10748426261540NA33206633202026-02-26
10748426144577Medline-MicrotekEquipment Drapes2222505H2026-02-18
10748426144638Medline-MicrotekEquipment Drapes61515RT2026-02-18
10748426144645Medline-MicrotekEquipment Drapes8838M2026-02-18
10748426144690Medline-MicrotekEquipment Drapes9951-202026-02-18
10748426144737Medline-MicrotekEquipment Drapes8900102026-02-18
10748426144744Medline-MicrotekEquipment Drapes8900162026-02-18
10748426144751Medline-MicrotekEquipment Drapes8900172026-02-18
10748426145468Medline-MicrotekEquipment Drapes99042026-02-18
10748426145475Medline-MicrotekEquipment Drapes99072026-02-18
10748426145505Medline-MicrotekEquipment Drapes29042026-02-18
10748426145512Medline-MicrotekEquipment Drapes46042026-02-18
10748426145529Medline-MicrotekEquipment Drapes46242026-02-18
10748426145536Medline-MicrotekEquipment Drapes49542026-02-18
10748426145543Medline-MicrotekEquipment Drapes49732026-02-18
10748426145550Medline-MicrotekEquipment Drapes59002026-02-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00849296004916Welmed, Inc.WELMED INC.PUI2026-03-20
20748426264487Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
20748426264494Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
10748426264503Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
00634916019353Standard SupremeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916120905Instrument HolderSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916781373WrapPel Table CoverSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916870633Instrument DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881202Circumcision Drape,STANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881226Split DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881233T-Lap Fenestrated DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
04052199810164Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810188Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810201Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04255575119459Sterile Cover KitRaguse Gesellschaft für medizinische Produkte mbHPUI2026-03-03
50198956294569CARDINAL HEALTHCardinal Health 200, LLCPUI2026-03-02
10748426261540NAMicrotek Medical LLCPUI2026-02-26
20197344179487MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-02-23
10197344179497MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-02-23
10748426144577Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144638Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144645Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144690Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144737Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144744Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144751Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145468Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145475Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145505Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145512Medline-MicrotekMicrotek Medical LLCPUI2026-02-18