FDA.reportPublic FDA data

n.a.

Primary DI
14250105612919
Brand
n.a.
Company
VBM Medizintechnik GmbH
Model
34-10-005
Device description
Pelvic Sling; Large L
Published
2020-08-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPWOrthosis, Sacroiliac, Soft

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPWOrthosis, Sacroiliac, SoftPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250105612919PackageGS11In Commercial Distribution
04250105612912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425010561291914250105612919
04250105612912042501056129124250105612912

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic binder, single-useA non-sterile, belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. It is typically intended to be used in an emergency setting to stabilize pelvic fractures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry, keep away from sunlight and heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49745495960info@vbm-medical.de

Regulatory Flags#

DUNS number
324869601
Device count
1
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
04250105630770ScalpelCric30-08-447-12026-05-08
04250105623048n.a.33-80-650-12020-09-02
04250105624243n.a.33-81-650-12020-09-02
04250105605150Quicktrach I30-04-002-12026-04-23
04250105605167Quicktrach I30-04-004-12026-04-23
04250105612462Quicktrach I30-04-904-12026-04-23
04250105613292Quicktrach I30-04-902-12026-04-23
14250105606024Tourniquet 250015-12-5002022-06-27
04250105630459Ambu® SureSight TM Stylet; large3219000302025-07-02
04250105630442Ambu® SureSight TM Stylet; medium3219000202025-07-02
04250105630435Ambu® SureSight TM Stylet; small3219000102025-07-02
14250105630449Ambu® SureSight TM Stylet; medium3219000202025-07-02
14250105630456Ambu® SureSight TM Stylet; large32190002302025-07-02
04250105628111n.a.30-08-447-12020-11-09
14250105628118n.a.30-08-447-12020-11-09
14250105630524Paediatric Mask; Newborn88-11-0002025-04-25
14250105630531Paediatric Mask; Infant88-11-0012025-04-25
14250105630548Paediatric Mask; Child88-11-0022025-04-25
24250105630521Paediatric Mask; Newborn88-11-0002025-04-25
24250105630538Paediatric Mask; Infant88-11-0012025-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04823097717769"TM ""Rehabilitimed"" GR-3P XXL Comfort"REABILITIMED TOVIPW2025-05-05
04823097717776"TM ""Rehabilitimed"" GR-3P XL Comfort"REABILITIMED TOVIPW2025-05-05
04823097717783"TM ""Rehabilitimed"" GR-3P L Comfort"REABILITIMED TOVIPW2025-05-05
04823097717790"TM ""Rehabilitimed"" GR-3P M Comfort"REABILITIMED TOVIPW2025-05-05
04823097717806"TM ""Rehabilitimed"" GR-3P S Comfort"REABILITIMED TOVIPW2025-05-05
04823097719794"TM ""Rehabilitimed"" GR-3P S Comfort"REABILITIMED TOVIPW2025-05-05
04823097719800"TM ""Rehabilitimed"" GR-3P M Comfort"REABILITIMED TOVIPW2025-05-05
04823097719817"TM ""Rehabilitimed"" GR-3P L Comfort"REABILITIMED TOVIPW2025-05-05
04823097719824"TM ""Rehabilitimed"" GR-3P XL Comfort"REABILITIMED TOVIPW2025-05-05
04823097719831"TM ""Rehabilitimed"" GR-3P XXL Comfort"REABILITIMED TOVIPW2025-05-05
B54180030080Pelvic BinderFARETEC, INC.IPW2024-02-28
B54180030050Pelvic BinderFARETEC, INC.IPW2023-03-16
B54180030000Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030010Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030020Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030030Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030040Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030060Pelvic BinderFARETEC, INC.IPW2023-03-15
B54180030070Pelvic BinderFARETEC, INC.IPW2023-03-15
00822045428614SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
00822045428621SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
00822045428638SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
00822045428645SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428611SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428628SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428635SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
10822045428642SAM Pelvic Sling IISAM Medical ProductsIPW2022-09-01
04250105612912n.a.VBM Medizintechnik GmbHIPW2020-08-31
04250105612905n.a.VBM Medizintechnik GmbHIPW2020-08-26
04250105623208n.a.VBM Medizintechnik GmbHIPW2020-08-26