FDA.reportPublic FDA data

Steri-Drape™

Primary DI
50707387456325
Brand
Steri-Drape™
Company
3M COMPANY
Model
9046
Catalog number
9046
Device description
9046 STERI-DRAPE ADHESVIE BILATERIAL SPLIT SHEET 15/BX 2BX/CS
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
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
50707387456325PackageGS12In Commercial Distribution
30707387456321PrimaryGS10
00707387456320Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5070738745632550707387456325
3070738745632130707387456321
00707387456320007073874563207073874563200707387456320

GMDN Terms

TermDefinition
Patient surgical drape, single-use, sterileA sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
830016148
Device count
15
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

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00634916120905Instrument HolderSTANDARD TEXTILE CO., INC.PUI2026-03-11
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00634916870633Instrument DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
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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
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04052199810201Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
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