FDA.reportPublic FDA data

Visitec

Primary DI
30886158106013
Brand
Visitec
Company
BEAVER-VISITEC INTERNATIONAL, INC.
Model
585721
Device description
Embossed Plastic Incise Drape with Fluid Collection Bag
Published
2016-09-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXDrape, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30886158106013PrimaryGS10
00886158106012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088615810601330886158106013
00886158106012008861581060128861581060120886158106012

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)906-8080customersupport@beaver-visitec
+1(866)906-8080customersupport@beaver-visitec.com

Regulatory Flags#

DUNS number
001406024
Device count
100
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886158106609BVIOME6000UOME6000U2025-08-11
00886158034247BVIFS6000FS60002025-07-22
00886158034674BVIELP19SU1ELP19SU12025-07-22
00886158034681BVIELP19CU1ELP19CU12025-07-22
00886158037569BVIFS6001FS60012025-07-22
00886158037576BVIOME6001UOME60012025-07-22
30886158032121CustomEyes®58001721580017212024-07-01
30886158032428CustomEyes®58001713580017132024-07-01
30886158032435CustomEyes®58001764580017642024-07-01
30886158032442CustomEyes®58001711580017112024-07-01
30886158032473CustomEyes®58001706580017062024-07-01
30886158032480CustomEyes®58001737580017372024-07-01
30886158032497CustomEyes®58001753580017532024-07-01
30886158032787CustomEyes®58001809580018092024-07-01
30886158032800CustomEyes®58001775580017752024-07-01
30886158032886CustomEyes®58001774580017742024-07-01
30886158032893CustomEyes®58001825580018252024-07-01
30886158032985CustomEyes®58001836580018362024-07-01
30886158033166CustomEyes®58001865580018652024-07-01
30886158033180CustomEyes®58001818580018182024-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975424198736Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.KKX2026-03-11
00812564036025MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036070MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036100MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036186MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036193MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036216MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036384MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10080196017010MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277636729MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660946MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660953MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10884389185780MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277635555MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10888277357037MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
26975424198832Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
16975424199276Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
10193489036954MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036961MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036978MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489036985MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
10193489040098MedlineMEDLINE INDUSTRIES, INC.KKX2026-02-11
20885632426299HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426312HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426329HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426336HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426343HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426350HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426367HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30
20885632426374HalyardOWENS & MINOR DISTRIBUTION, INC.KKX2026-01-30