FDA.reportPublic FDA data

MEDLINE

Primary DI
10197344160945
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
SPD212N
Catalog number
SPD212N
Device description
FISTULAGRAM DRP 45X60IN
Published
2025-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, surgical, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344160942PrimaryGS10
10197344160945Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734416094220197344160942
1019734416094510197344160945

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
25
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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