FDA.reportPublic FDA data

Symmetry Bookwalter®

Primary DI
00887482018644
Brand
Symmetry Bookwalter®
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
50-4591
Catalog number
50-4591
Device description
Bookwalter® Retractor, Blade, Magrina Lateral, 1 in x 3 in, (25 mm x 76 mm)
Published
2022-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDKScissors, Episiotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDKScissors, EpisiotomyObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482018644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482018644008874820186448874820186440887482018644

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth3Inch
Width1Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047003205GimmiGimmi GmbHHDK2025-04-22
04049047003212GimmiGimmi GmbHHDK2025-04-22
04049047003229GimmiGimmi GmbHHDK2025-04-22
04049047679844GimmiGimmi GmbHHDK2025-04-22
04049047679851GimmiGimmi GmbHHDK2025-04-22
00840183526207BR Surgical, LLCBR Surgical, LLCHDK2024-03-28
G586OB6441260Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
G586OB96442290Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
00190776050337AvalignAvalign Technologies, Inc.HDK2023-09-28
00190776250621AvalignAvalign Technologies, Inc.HDK2023-09-28
07898506853847QuinelatoSchobell Industrial LtdaHDK2023-07-11
00190776250669AvalignAvalign Technologies, Inc.HDK2023-06-23
00840183513542BR Surgical, LLCBR Surgical, LLCHDK2023-04-14
07898506852406QuinelatoSchobell Industrial LtdaHDK2023-01-11
14026704792105PILLINGTELEFLEX INCORPORATEDHDK2022-12-08
54026704792103PILLINGTELEFLEX INCORPORATEDHDK2022-12-08
00842331161261Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331167171Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331171772Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00887482024171Symmetry BraunASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00887482039465Symmetry Braun-StadlerASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00887482039472Symmetry WaldmannASPEN SURGICAL PRODUCTS, INC.HDK2022-09-21
00190660157180Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
00190660157197Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
04046826070595MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046826070618MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046955086597AESCULAPAESCULAP, INC.HDK2020-05-06
04038653042470AESCULAPAesculap AGHDK2020-04-20
04038653042487AESCULAPAesculap AGHDK2020-04-20
10381780500612Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDK2018-09-18