FDA.reportPublic FDA data

Symmetry CLASSIC®

Primary DI
00887482034132
Brand
Symmetry CLASSIC®
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
53-1537HD
Catalog number
53-1537HD
Device description
Classic Kerrison Rongeur; Thin Footplate Bayonet
Published
2016-06-01
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482034132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482034132008874820341328874820341320887482034132

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

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
10840113232908BovieAA002026-09-21
10840113232922BovieAA00X2026-09-21
10840113232946BovieAA012026-09-21
10840113232960BovieAA01X2026-09-21
10840113232984BovieAA022026-09-21
10840113233004BovieAA032026-09-21
10840113233028BovieAA03X2026-09-21
10840113233042BovieAA042026-09-21
10840113233066BovieAA04X2026-09-21
10840113233080BovieAA052026-09-21
10840113233165BovieAA212026-09-21
10840113233189BovieAA21X2026-09-21
10840113233264BovieAA902026-09-21
10840113233547BovieAA05X2026-09-21
10840113234407BovieES232026-09-21
10840113234414BovieES22-82026-09-21
10840113236838BovieES032026-09-21
10840113236845BovieES022026-09-21
10840113236852BovieES02T2026-09-21
10840113236876BovieES012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995311759V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311766V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311865V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311872V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311889V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311964V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311971V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311988V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311995V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312008V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312015V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312077V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312084V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312091V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312107V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00190776432331MillenniumAvalign Technologies, Inc.HAE2026-09-24
04250325493537VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301713VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301720VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301737VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
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04255968301843VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301850VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301867VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301874VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301959VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
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04255968301973VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22