PERLA ® TL
- Primary DI
- 07640332476284
- Brand
- PERLA ® TL
- Company
- SpineArt SA
- Model
- TLF-IN 21 00-N
- Catalog number
- TLF-IN 21 00-N
- Device description
- C-CHISEL
- Published
- 2023-11-03
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K231069 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07640332476284 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07640332476284 | 07640332476284 | 7640332476284 |
GMDN Terms#
| Term | Definition |
|---|---|
| Bone lever/elevator, reusable | A 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 |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 483016148
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07640221373021 | PERLA NAV | NAV-IN 11 50-N | NAV-IN 11 50-N | 2026-05-07 |
| 07640221373038 | PERLA ® TL | HAN-FI BA 50-N | 2026-05-07 | |
| 07640221373045 | PERLA ® TL | TLF-IN 01 60-N | 2026-05-07 | |
| 07640221373052 | PERLA NAV | NAV-IN 43 30-N | NAV-IN 43 30-N | 2026-05-07 |
| 07640221373069 | PERLA NAV | NAV-IN 43 60-N | NAV-IN 43 60-N | 2026-05-07 |
| 07640221373076 | PERLA ® TL | TLF-IN 03 70-N | 2026-05-07 | |
| 07640221373083 | PERLA ® TL | TLF-IN 12 00-N | 2026-05-07 | |
| 07640221373090 | PERLA ® TL | TLF-IN 04 70-N | 2026-05-07 | |
| 07640221373113 | PERLA NAV | NAV-IN 41 75-N | NAV-IN 41 75-N | 2026-05-07 |
| 07640221373120 | PERLA NAV | NAV-IN 41 80-N | NAV-IN 41 80-N | 2026-05-07 |
| 07640221373137 | PERLA NAV | NAV-IN 41 85-N | NAV-IN 41 85-N | 2026-05-07 |
| 07640221373144 | PERLA NAV | NAV-IN 41 90-N | NAV-IN 41 90-N | 2026-05-07 |
| 07640221373151 | PERLA NAV | NAV-IN 41 95-N | NAV-IN 41 95-N | 2026-05-07 |
| 07640221373168 | PERLA NAV | NAV-IN 41 00-N | NAV-IN 41 00-N | 2026-05-07 |
| 07640221373175 | PERLA NAV | NAV-IN 41 05-N | NAV-IN 41 05-N | 2026-05-07 |
| 07640221373182 | PERLA NAV | NAV-IN 41 10-N | NAV-IN 41 10-N | 2026-05-07 |
| 07640221373199 | PERLA NAV | NAV-IN 41 15-N | NAV-IN 41 15-N | 2026-05-07 |
| 07640221373205 | PERLA NAV | NAV-IN 41 20-N | NAV-IN 41 20-N | 2026-05-07 |
| 07640221373212 | PERLA NAV | NAV-IN 41 25-N | NAV-IN 41 25-N | 2026-05-07 |
| 07640221373229 | PERLA NAV | NAV-IN 42 70-N | NAV-IN 42 70-N | 2026-05-07 |
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