FDA.reportPublic FDA data

Susol® Diamond Bur Pear 2

Primary DI
05060418832377
Brand
Susol® Diamond Bur Pear 2
Company
BAILEY INSTRUMENTS LTD
Model
S-DB18
Published
2024-02-27
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

Product Codes#

Code, Name table
CodeName
GFFBur, Surgical, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060418832377PackageGS1100In Commercial Distribution
05060418833695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060418832377050604188323775060418832377
05060418833695050604188336955060418833695

GMDN Terms#

Term, Definition table
TermDefinition
Podiatric bur, single-useA rotary abrasive device typically used by a podiatrist intended to debride excrescences and treat conditions such as heavy toenails and/or plantar calluses. It consists of a well-differentiated head of various shapes (e.g., cone, cylinder, inverted cone, pear) made of hard materials (e.g., diamond, metal carbide), and a tapered, notched or elongated proximal end intended to fit into an appropriate powered handpiece (not included); it may be composed of two separate pieces. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
769260357
Device count
1
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
true
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
05060418834661Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833343Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833695Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418833725Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418833732Susol® Diamond Bur 15CS-DB72024-02-27
05060418833749Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418833992Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418834012Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418834029Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418833671Susol® Emery Board 18cmCH1452024-02-27
05060418832407Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418832414Susol® Diamond Bur 15CS-DB72024-02-27
05060418832421Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418832674Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418832698Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418832704Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418836177Susol® Micro Curette Double Ended with holeSS62-43002024-02-27
05060418834883 Susol® Nail Care SetBSDP-022024-02-20
05060418833640 Susol® Nail Care SetBSDP-022024-02-20
05060418836696Susol® Standard Suture Pack (Pack of 10)SSP-021-F2024-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000108G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000109G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000402AU1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000404A21KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000106AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-27
E226000104AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
E226000104G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
05051471027725De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471030152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089792De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089808De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089815De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089839De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29