FDA.reportPublic FDA data

Hollister

Primary DI
20610075049459
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
9775
Catalog number
9775
Device description
Wound Drainage Collector
Published
2022-12-01
Public version status
New
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
GDSBAG, STOMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDSBag, StomalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075049459PackageGS16In Commercial Distribution
10610075097750PrimaryGS10
00610075072590Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007504945920610075049459
1061007509775010610075097750
00610075072590006100750725906100750725900610075072590

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter9.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags#

DUNS number
005527098
Device count
10
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075098217Hollister982198212022-12-01
00610075098224Hollister982298222022-12-01
00610075098231Hollister982398232022-12-01
00610075098804Hollister988098802022-12-01
00610075040070InstaFlo330162016-09-21
00610075179626ActiFlo320042016-09-21
00610075179633ActiFlo320052016-09-21
00610075179640ActiFlo320062016-09-21
00610075179657ActiFlo320072016-09-21
10610075180292Advance Plus Pocket93104IC93104IC2016-09-21
10610075180308Advance Plus Pocket93124IC93124IC2016-09-21
10610075180315Advance Plus Pocket93144IC93144IC2016-09-21
10610075180322Advance Plus Pocket93164IC93164IC2016-09-21
00610075077243Hollister772477242022-12-01
00610075077281Hollister772877282022-12-01
00610075095667VaPro Plus Pocket Kit79089K79089K2024-07-15
00610075095674VaPro Plus Pocket Kit79109K79109K2024-07-15
00610075095681VaPro Plus Pocket Kit79129K79129K2024-07-15
00610075095698VaPro Plus Pocket Kit79149K79149K2024-07-15
00610075095704VaPro Plus Pocket Kit79169K79169K2024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898616351431OstomyGelDMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDAGDS2025-04-28
10885632431173HalyardO&M HALYARD, INC.GDS2024-11-12
10885632431180HalyardO&M HALYARD, INC.GDS2024-11-12
10885632431197HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431170HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431187HalyardO&M HALYARD, INC.GDS2024-11-12
20885632431194HalyardO&M HALYARD, INC.GDS2024-11-12
00610075097722HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00610075097753HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00610075097777HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097726HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097757HollisterHOLLISTER INCORPORATEDGDS2023-04-07
20610075097771HollisterHOLLISTER INCORPORATEDGDS2023-04-07
00618029980274Stryker Fecal Management SystemSAGE PRODUCTS, LLCGDS2023-03-07
50618029980279Stryker Fecal Management SystemSAGE PRODUCTS, LLCGDS2023-03-07
10610075097729HollisterHOLLISTER INCORPORATEDGDS2022-12-01
10610075097750HollisterHOLLISTER INCORPORATEDGDS2022-12-01
10610075097774HollisterHOLLISTER INCORPORATEDGDS2022-12-01
20610075049367HollisterHOLLISTER INCORPORATEDGDS2022-12-01
20610075049497HollisterHOLLISTER INCORPORATEDGDS2022-12-01
00610075097739HollisterHOLLISTER INCORPORATEDGDS2022-09-21
00610075097760HollisterHOLLISTER INCORPORATEDGDS2022-09-21
00610075097784HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097733HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097764HollisterHOLLISTER INCORPORATEDGDS2022-09-21
20610075097788HollisterHOLLISTER INCORPORATEDGDS2022-09-21