FDA.reportPublic FDA data

VALVE XS

Primary DI
04046963756659
Brand
VALVE XS
Company
Aesculap AG
Model
FC146R
Catalog number
FC146R
Device description
VALVE XS Retractor, universal connecting clamp, Type A, non-sterile, reusable
Published
2020-04-24
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXDCLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963756659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963756659040469637566594046963756659

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, reusableA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896122680Schroeder Vulsellum Bone ClampSONTEC INSTRUMENTS, INC.HXD2026-03-10
B356JD259280American MedicalsAmerican MedicalsHXD2026-03-09
00190776416706MillenniumAvalign Technologies, Inc.HXD2026-02-20
00190776415877MillenniumAvalign Technologies, Inc.HXD2026-02-04
00810123209781Adler Instrument CompanyAdler, Inc.HXD2026-01-28
00810123209798Adler Instrument CompanyAdler, Inc.HXD2026-01-28
00841013124532American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124549American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124556American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00841013124563American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.HXD2026-01-05
00888480670728Timberline Lateral Fusion SystemHighridge Medical, LLCHXD2025-12-18
05060624126697CS Fixed Blade ClampCARE SURGICAL LIMITEDHXD2025-12-17
03662663196741Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
03662663196758Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
03662663196796Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHXD2025-12-15
09421038410479Enztec Inverted Premium Patella ClampENZTEC LIMITEDHXD2025-12-11
09421038410486Enztec Premium Cement Clamp - RotatingENZTEC LIMITEDHXD2025-12-11
00840277133113Innomed, Inc.INNOMED, INC.HXD2025-12-02
00840338603685Tornier HRS MaxTORNIER, INC.HXD2025-11-18
00840338603944Tornier HRS MaxTORNIER, INC.HXD2025-11-18
03662663137027Polaris 4.75 Deformity SystemHighridge Medical, LLCHXD2025-11-14
00840277133038Innomed, Inc.INNOMED, INC.HXD2025-11-12
00885556768471EVOSSmith & Nephew, Inc.HXD2025-11-12
00885556908846EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911112EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911129EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911136EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911143EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911150EVOSSmith & Nephew, Inc.HXD2025-11-11
00885556911167EVOSSmith & Nephew, Inc.HXD2025-11-11