FDA.reportPublic FDA data

3 Prichard Periosteal

Primary DI
00810060723104
Brand
3 Prichard Periosteal
Company
Berman Instruments LLC
Model
PPR03
Published
2022-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060723104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060723104008100607231048100607231040810060723104

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118744340
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810060722015Adson Tissue ForcepsAF0012022-09-22
00810060722039Aspirating Syringe 1.8 mlAS0182022-09-22
00810060722077Lucas Curette #85BC085 2022-09-22
00810060722084Lucas Curette #87BC0872022-09-22
00810060722091Lucas Curette #88BC0882022-09-22
008100607221072R/2L Columbia Curette CC022 2022-09-22
008100607221144R/4L Columbia Curette CC044 2022-09-22
0081006072212113/14 Columbia CuretteCC1342022-09-22
008100607221381/2 Gracey CG012 2022-09-22
0081006072214511/12 Gracey CG112 2022-09-22
0081006072215213/14 Gracey CG134 2022-09-22
0081006072220613K/TG Kirkland Periodontal ChiselCKP13 2022-09-22
008100607222204 Ochsenbein Surgical Chisel, 3.4 mmCOS04 2022-09-22
00810060722237College Pliers, Serrated Tips CP001 2022-09-22
00810060722244113 Non-serrated Cord Packer CP113 2022-09-22
00810060722251College Pliers, Self-locking, Serrated Tips CPL02 2022-09-22
00810060722558Rubber dam punch DF002 2022-09-22
00810060722657Molt #2 Surgical CuretteEP002 2022-09-22
00810060722930Molt Mouth Prop - Adult MA002 2022-09-22
00810060722947Metal Bowl - Prep CupMBPC352 2022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456224861JMUJMU DENTAL, INCEMN2026-09-30
00840456224878JMUJMU DENTAL, INCEMN2026-09-30
00840456224885JMUJMU DENTAL, INCEMN2026-09-30
00840456224892JMUJMU DENTAL, INCEMN2026-09-30
00840456224908JMUJMU DENTAL, INCEMN2026-09-30
00840456224915JMUJMU DENTAL, INCEMN2026-09-30
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06973042243220Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30