FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955206797
Brand
AESCULAP
Company
Aesculap AG
Model
PV022
Catalog number
PV022
Device description
SOFTWARE MODULE DUV 400
Published
2020-05-08
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
FSOMICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955206797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955206797040469552067974046955206797

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical microscopeA light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light. It will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It is usually fixed.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653434022AESCULAPFT944TFT944T2015-09-24
04046963417468AESCULAPFT942TFT942T2015-09-24
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906168451499Prima Lite Surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451505Prima Lite Surgical Microscope Wall mountLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451512Prima Lite ENT Surgical MicroscopesLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451529Prima Lite trainerLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451536Prima Swift surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451543Prima Pro surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451550Prima Pro surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451567Prima Floor Stand with ColumnLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
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