FDA.report

ELAN 4

Primary DI
04046964769375
Brand
ELAN 4
Company
Aesculap AG
Model
GP528R
Catalog number
GP528R
Device description
SAW BLADE L SAGITTAL 20/15/8
Published
2019-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications

CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046964769375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046964769375040469647693754046964769375

GMDN Terms

TermDefinition
Oscillating surgical saw blade, reusableA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90? angle to its shaft. It cuts when it is moved in a rapid oscillating motion. This device enables side-cutting action to be performed within a restricted-access area. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
false
Premarket exempt
false
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 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 DIBrandCompanyProduct codePublished
04589551366583Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366590Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366606Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
04589551366613Sterile Cutting ToolNAKANISHI INC.HBE2026-05-22
B775635CK0PHASORPHASOR HEALTH LLCHBE2026-01-19
B7752IN125LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN126LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7752IN145LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1246LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7753IN1256LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1K0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7754IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B7755IN1LK0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDBA0PHASORPHASOR HEALTH LLCHBE2025-11-24
B775GREDRI0PHASORPHASOR HEALTH LLCHBE2025-11-24
00763000679682POWEREASE™ InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HBE2025-07-28
00763000683511POWEREASE™ InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HBE2025-07-27
00763000722388MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722319ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-25
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBE2025-07-17
00763000892722Midas Rex ClearviewMEDTRONIC XOMED, INC.HBE2025-06-23
06429811532069Surgify Halo | 4.0 mm | ShortSurgify Medical OyHBE2025-06-18
06429811532076Surgify Halo | 4.0 mm | ExtendableSurgify Medical OyHBE2025-06-18
06429811532083Surgify Halo | 4.0 mm | LongSurgify Medical OyHBE2025-06-18
15059358034986ZethonZETHON LIMITEDHBE2025-05-14
05059358036457ZethonZETHON LIMITEDHBE2025-05-14
15059358036478ZethonZETHON LIMITEDHBE2025-05-14