FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963909338
Brand
AESCULAP
Company
Aesculap AG
Model
PL595SU
Catalog number
PL595SU
Device description
SILICONE RING WITH NEEDLE
Published
2020-05-04
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963915025PrimaryGS10
04046963909338Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963915025040469639150254046963915025
04046963909338040469639093384046963909338

GMDN Terms#

Term, Definition table
TermDefinition
Medical/surgical stringA sterile slender cord or thick thread, medical grade, designed to temporarily lift vessels, hold tracheostomy tubes in place, or assist in stabilizing various organs, medical instrumentation and accessories. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315018218
Device count
12
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD907505200Surgical DirectSurgical Direct, Inc.GDG2026-07-17
B382SD907505210Surgical DirectSurgical Direct, Inc.GDG2026-07-17
00190776395674MillenniumAvalign Technologies, Inc.GDG2026-07-14
00810158216136PRINCETONPrinceton Medical Group, Inc.GDG2026-06-23
B7685252430Buxton BioMedicalBuxton Biomedical IncGDG2026-06-05
G383S1061WM3245624S7SURJEXSURJEXGDG2026-05-31
00810055258734Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258741Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258758Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258765Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258772Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258789Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258796Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258802Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258819Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258826Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258833Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258840Surgical DesignSurgical Design, Inc.GDG2026-05-29
09348811019622INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
09348811019639INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-21
10381780503194Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503200Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503729Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503736Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780503798Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2019-02-19
10381780449195Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-12-19
10381780495833Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-10-24
10381780498681Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780498698Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18
10381780498704Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDG2018-09-18